The Law, Policy, and Ethics Core (LPEC) provides support for the Western Regional Center of Excellence for Biodefense and Emerging Infectious Diseases Research (WRCE) through research, study, and analysis of policy, laws, and regulations which impact research and scientists in biodefense. Areas of focus for the LPEC include federal policy, law, and regulations;and international aspects of: (1) select agents, (2) dual use issues in scientific publications, (3) animal and primate testing, (4) vaccine and approval processes, (5) human subject testing, and (6) intellectual property. These areas support the WRCE scientific program development of therapeutics, diagnostics, and vaccines for Category A-C agents, and can potentially support the work of biodefense researchers in all Centers of Excellence in crosscutting areas of interest in law, policy, and ethics. A function of the LPEC is to evaluate questions regarding policy, law, and ethics that may be raised during the course of the work of WRCE investigators. The analysis and work of the core will involve the partners' participation in discussions of law, policy, and ethics relative to the areas of focus of the LPEC. Through open dialogue and discussion, the LPE Core will strive to impact policy and regulations in a manner conducive to furthering the research goals of the RCE scientists.